FDA approves Novartis drug for rare blood disorder

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

The FDA announced the approval of Novartis’ Exjade (deferasirox) for patients ages 10 years and older with chronic iron overload resulting from nontransfution-dependent thalassemia, or NTDT. A companion diagnostic, FerriScan, made by Australia-based Resonance Health, also was approved.

NTDT is a mild form of thalassemia that, unlike the more severe form of the disease, does not require frequent red blood cell transfusions. However, both disorders cause iron overload that can damage vital organs. According to the National Heart, Lung and Blood Institute, part of the National Institutes of Health, about 1,000 people in the United States have thalassemia.

The drug was previously approved for treating chronic iron overload due to blood transfusions in patients ages 2 years and older.

Parents not very concerned about prescription narcotic misuse, poll finds

ANN ARBOR, Mich. — A new study indicated that some parents may not be sufficiently concerned about misuse of narcotic painkillers by children and teenagers.

The University of Michigan Mott Children’s Hospital National Poll on Children’s Health indicated that overall, 35% of parents said they were "very concerned" about misuse of narcotic pain drugs in their communities, while 19% showed similar concern about misuse in their own families. While 38% of black parents and 26% of Hispanic parents expressed such strong concern about misuse of narcotics, only 13% of white parents did, though rates of narcotic pain use have been shown to be three times higher among white teenagers than among their black and Hispanic peers.

"Recent estimates are that 1-in-4 high school seniors have ever used a narcotic pain medicine," poll associate director and Sarah Clark said. "However, parents may downplay the risks of narcotic pain medicine because they are prescribed by a doctor."

The poll also found that 35% of parents report that they had received at least one pain medicine prescription for their children in the last five years, and more than half of those were for narcotics. Two-thirds had received at least one pain drug for themselves or another adult in the household. National data have indicated that the number of overdose deaths from narcotic pain drugs is more than those from heroin and cocaine combined, according to the poll.

"This is a national problem and a growing problem," Clark said. "The results of this poll are a signal that parents may not be aware of the significant rates of misuse of narcotic pain medicine, which highlights the tremendous challenge of addressing this national problem."

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Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
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Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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